Pharmacokinetics of BIA 9-1067 in Subjects With Hepatic Impairment

Exclusion Criteria

• •1. Presence or history of any disorder that may prevent the successful completion of the study. Allergies and Adverse Drug Reactions
• •2. History of multiple and/or severe allergies to drugs or foods or a history of anaphylactic reactions.
• •3. Known or suspected allergy or other adverse drug reactions to the trial product or related products (e.g tolcapone or entacapone).
• •4. Positive pregnancy test result (serum Beta-HCG) for women of childbearing potential only.
• •5. Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or cola), grapefruit, grapefruit-containing products, or alcoholic beverages from 48 hours before study day 1 until the end of the inpatient confinement period.
• •6. Involvement in other investigational studies of any type within 30 days of BIA 9-1067 administration.
• •7. Donation of blood within 90 days of study day 1.
• •8. Evidence of unstable clinically significant disease other than impaired hepatic function (e.g., cardiovascular, cerebrovascular, respiratory, renal disease, or any serious disorder that currently requires a physician's care).
• •9. Recent history or presence of any disorder that may interfere with the absorption, distribution, metabolism, or excretion of BIA 9-1067 (except hepatic impairment).
• •10. Patients with severe encephalopathy.
• •11. Acute exacerbation of hepatic disease, as indicated by worsening of clinical and/or laboratory signs of hepatic impairment, within the 2 weeks before BIA 9-1067 administration (eg, advanced ascites, infection of ascites, fever, hepatic encephalopathy or active gastrointestinal bleeding (hematemesis, melena), significant abdominal pain, persistent nausea and vomiting, or a worsening of total bilirubin or prothrombin time by \>50%).
• •12. Presence of a hepatocellular carcinoma, or an acute hepatic disease caused by infection or drug toxicity.
• •13. Presence of surgically created portal-systemic shunt.
• •14. Positive serologic finding for human immunodeficiency virus (HIV) antibodies.
• •15. Prescription and over-the-counter (OTC) medication doses must be stable for 7 days before IMP administration.
• •Healthy Matched Subjects only:
• •16. History of alcoholism or excessive daily alcohol consumption within the past year. Excessive alcohol consumption is regarded as an average weekly intake of more than 14 units for women and 21 units for men (1 unit of alcohol = 8 to 10 g and is approximately equivalent to 1 glass of wine or 250 mL of beer or a standard measure of spirits).
• •17. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
• •18. Any clinically important deviation from normal limits in physical examination, vital signs, or 12-lead ECGs.
• •19. Acute disease state (e.g., nausea, vomiting, fever, diarrhea) within 7 days of study day 1.
• •20. Positive serologic findings for HIV antibodies, hepatitis B surface antigen (Hbs Ag), and/or hepatitis C virus (HCV) antibodies.
• •21. Recent history or presence of any disorder that may interfere with the absorption, distribution, metabolism, or excretion of BIA 9-1067.
• •22. Use of any prescription drug within 30 days of IMP administration.
• •23. Use of any OTC drugs including herbal supplements (except for the occasional use of acetaminophen and vitamins ≤100% recommended daily allowance) within 14 days of study day 1.